Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation

MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.

SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.

Study Overview

• Status: Unknown
• Conditions: Astigmatism; Visual Acuity; IOL; Cataract After
• Intervention / Treatment: Other: Kind of trifocal IOL

Detailed Description

It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.

• Study Type: Observational
• Enrollment (Anticipated): 48

Contacts and Locations

• Study Contact: Name: Enrique Ordiñaga-Monreal, OD; Phone Number: 934179803; Email: e.ordinaga@clinicatacir.com

Study Locations

• Spain
  • Barcelona, Spain, 08022
    • Recruiting
    • Clinica Oftalmológica TACIR
    • Contact: Ordiñaga-Monreal Enrique, OD; Phone Number: 934179803; Email: e.ordinaga@clinicatacir.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.

Description

Inclusion Criteria:

• Bilateral surgery performed by the same surgeon
• IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
• Patients with pre-surgery corneal astigmatism less than 2.5 D
• Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.

Exclusion Criteria:

• Post-surgical refractive residual astigmatisms ≧ 1.55D
• Previous corneal or intraocular surgeries
• Active diseases
• Eye complications during the 3-month follow-up

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Trifocal IOL(Finevision IOL, PhysIOL); We will divide the sample into two groups of patients depending on the IOL implanted First group: FineVision	Other: Kind of trifocal IOL; Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D; Other Names: FineVision IOL; FineVision Toric IOL
Trifocal toric IOL (Finevision Toric IOL, PhysIOL); We will divide the sample into two groups of patients depending on the IOL implanted: Second group: FineVisionToric	Other: Kind of trifocal IOL; Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D; Other Names: FineVision IOL; FineVision Toric IOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity will be measured at distance, intermediate distance (67 cm) and near (40 cm). Visual acuities will be obtained with logarithmic notation	3 months following cataract surgery
Contrast Sensitivity Function (CSF)	Contrast sensitivity will be measured at far, intermediate distance (67 cm) and near (40 cm).	3 months following cataract surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differences between groups	Results will be compared between groups.	3 months following cataract surgery

Collaborators and Investigators

• Sponsor: Enrique Ordiñaga-Monreal, OD, MSc
• Investigators: Principal Investigator: Enrique Ordiñaga-Monreal, OD, Clinica Oftalmológica TACIR

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Contrast Sensitivity; CSF; Trifocal IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: EC042019; 2019/65-OFT-CMT (Other Identifier: CEIm Grupo Hospitalario Quirónsalud-Catalunya)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No